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Vitamin K antagonists after all, or possibly not?
Antagonistas da vitamina K todavia, ou nem por isso?
Victor Machado Gil
Serviço de Cardiologia, Hospital dos Lusíadas, Lisboa, Portugal
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"tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "467" "paginaFinal" => "468" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Victor Machado Gil" "autores" => array:1 [ 0 => array:3 [ "nombre" => "Victor" "apellidos" => "Machado Gil" "email" => array:1 [ 0 => "victorgilmd@gmail.com" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Serviço de Cardiologia, Hospital dos Lusíadas, Lisboa, Portugal" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "pt" => array:1 [ "titulo" => "Antagonistas da vitamina K todavia, ou nem por isso?" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Atrial fibrillation (AF) is a major public health problem, with an estimated prevalence of 2.5% in the Portuguese population aged 40 and over according to the results of the FAMA study published in 2010.<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">1</span></a> Only 37.8% of patients in the study were taking vitamin K antagonists (VKAs).</p><p id="par0010" class="elsevierStylePara elsevierViewall">One of the main limitations of chronic VKA therapy for the prevention of thromboembolism is the narrow therapeutic window for these drugs, international normalized ratio (INR) values often oscillating between reduced protection when below therapeutic levels and increased bleeding risk when above. The difficulty in maintaining patients within the therapeutic range (as reflected by percentage time in therapeutic range [TTR]) stems from the numerous interactions and complexity of warfarin metabolism. A TTR of >70% is considered ideal but this value is rarely achieved, even in patients with good control. In the large-scale clinical trials of the new oral anticoagulants (NOACs), TTR in the warfarin arm was 66% in RELY<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">2</span></a> (vs. dabigatran), 55% in ROCKET-AF<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">3</span></a> (vs. rivaroxaban), 62.2% in ARISTOTLE<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">4</span></a> (vs. apixaban) and 64.9% in ENGAGE<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">5</span></a> (vs. edoxaban).</p><p id="par0015" class="elsevierStylePara elsevierViewall">A study of AF patients in the UK General Practice Research Database included 27<span class="elsevierStyleHsp" style=""></span>458 warfarin-treated patients and 10<span class="elsevierStyleHsp" style=""></span>449 patients not treated with antithrombotic therapy. The mean TTR of treated patients was 63%. However, risk reduction is clearly proportional to the effectiveness of anticoagulation control, the above study reporting a 79% reduced risk of stroke in patients who had TTR of ≥70% compared to those with TTR of ≤30%.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">6</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Furthermore, bleeding risk is also proportional to the level of anticoagulation achieved, rising significantly with INR of >4, particularly in the first three months of therapy.<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">7,8</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">In a study by Luís Cunha on admissions for ischemic stroke to the Neurology Department of Coimbra University Hospitals during the first trimester of 2011,<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">9</span></a> 37.3% were of cardioembolic etiology, of which 95% were in the context of AF. Of these, only 34.7% of patients were taking VKAs and only 11% had INR within the therapeutic range.</p><p id="par0030" class="elsevierStylePara elsevierViewall">In an observational study published in 2015 of patients aged ≥30 years with a diagnosis of AF registered at eight family health units in Vila Nova de Gaia in northern Portugal,<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">10</span></a> the prevalence of AF was lower than reported in the FAMA study (1.29% vs. 2.5%) and only 56.8% of patients with indication for oral anticoagulation were receiving this therapy.</p><p id="par0035" class="elsevierStylePara elsevierViewall">The study by Guedes and Rego published in this issue of the <span class="elsevierStyleItalic">Journal</span><a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">11</span></a> was of 26 healthcare units with oral anticoagulation programs (73% of the total) of the Espinho-Gaia and Gaia health center groups. It included 5883 INR records corresponding to 479 patients with non-valvular AF under chronic oral anticoagulation therapy with VKAs. Mean TTR was 67.4%, varying between 55.6% and 79.5% among the different units. The results were on a par with the best reported in the world. For example, in the control group of the ROCKET-AF clinical trial,<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">12</span></a> individual TTR (iTTR) was 66% in Western Europe and 65.8% in Canada and the US. Some units even had better values than the leading country in this field, Sweden, where mean TTR was 75% in this patient group.</p><p id="par0040" class="elsevierStylePara elsevierViewall">These results clearly show that a motivated and dedicated group can make a difference in improving care. They demonstrate that a well-executed anticoagulation program can achieve high levels of effectiveness, even in Portugal. However, the situation in Gaia contrasts with the latest data for the country as a whole, particularly those of the SAFIRA study,<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">13</span></a> presented at the last Portuguese Congress of Cardiology. The study included 7500 patients aged ≥65 years, followed in primary care and in district and tertiary hospitals. Overall AF prevalence was 9%, and only 43.7% were treated with anticoagulants (two-thirds with VKAs and one third with NOACs). Mean TTR among patients taking VKAs was 41.7%. Experience with coordinating anticoagulation programs suggests that this is more in line with the real situation.</p><p id="par0045" class="elsevierStylePara elsevierViewall">The criterion adopted by Guedes and Rego for inclusion in the study was a minimum of six visits for INR testing in 2014. This was a cross-sectional retrospective analytical study, with no longitudinal information, and so the start date or duration of anticoagulation therapy are not known. It would also be useful to know the level of patient adherence to the program over time, given the high rate of discontinuation of such therapy (20-25% in clinical trials of NOACs). Nevertheless, the results are impressive.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Many argue that when there is good control of VKA therapy (TTR >70), the NOACs lose their advantage in terms of clinical efficacy. This does not, however, appear to be the case. Although the best results with the NOACs are obtained in groups with lower TTR,<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">14</span></a> the treatment effect of various NOACs compared with warfarin for the prevention of cardiothromboembolism is maintained across different levels of TTR.<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">15,16</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">It would be useful to compare the methodology of the Gaia group with that employed in other regions reporting worse results, with a view to improving their performance. Optimizing the organizational and logistical aspects of oral anticoagulation programs with VKAs would certainly have a favorable clinical impact. However, even compared to programs like that of the Gaia group with optimized VKA therapy, in my opinion the NOACs remain the best treatment option, even in clinically similar subgroups, due to their convenience, lower rate of intracranial hemorrhage and virtual absence of dietary interference, as well as a proven good cost-effectiveness ratio.<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">17</span></a> In addition, the issue of the lack of an antidote has already been resolved for one of the NOACs and is in the process of being resolved for the others.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0060" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflicts of interest" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Machado Gil V. AVK todavia, ou nem por isso? Rev Port Cardiol. 2016;35:467–468.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:17 [ 0 => array:3 [ "identificador" => "bib0090" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Prevalência de fibrilhação auricular na população portuguesa com 40 ou mais anos. Estudo FAMA" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "D. Bonhorst" 1 => "M. Mendes" 2 => "P. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 8 | 9 | 17 |
| 2024 October | 36 | 33 | 69 |
| 2024 September | 43 | 24 | 67 |
| 2024 August | 34 | 23 | 57 |
| 2024 July | 30 | 32 | 62 |
| 2024 June | 27 | 22 | 49 |
| 2024 May | 26 | 30 | 56 |
| 2024 April | 28 | 20 | 48 |
| 2024 March | 33 | 22 | 55 |
| 2024 February | 39 | 35 | 74 |
| 2024 January | 25 | 31 | 56 |
| 2023 December | 30 | 31 | 61 |
| 2023 November | 30 | 19 | 49 |
| 2023 October | 23 | 15 | 38 |
| 2023 September | 35 | 15 | 50 |
| 2023 August | 22 | 24 | 46 |
| 2023 July | 21 | 12 | 33 |
| 2023 June | 22 | 20 | 42 |
| 2023 May | 29 | 17 | 46 |
| 2023 April | 24 | 7 | 31 |
| 2023 March | 31 | 26 | 57 |
| 2023 February | 23 | 17 | 40 |
| 2023 January | 29 | 15 | 44 |
| 2022 December | 32 | 26 | 58 |
| 2022 November | 34 | 20 | 54 |
| 2022 October | 32 | 14 | 46 |
| 2022 September | 13 | 38 | 51 |
| 2022 August | 38 | 37 | 75 |
| 2022 July | 29 | 33 | 62 |
| 2022 June | 24 | 12 | 36 |
| 2022 May | 25 | 29 | 54 |
| 2022 April | 20 | 30 | 50 |
| 2022 March | 28 | 31 | 59 |
| 2022 February | 15 | 16 | 31 |
| 2022 January | 27 | 24 | 51 |
| 2021 December | 23 | 28 | 51 |
| 2021 November | 33 | 37 | 70 |
| 2021 October | 23 | 36 | 59 |
| 2021 September | 16 | 25 | 41 |
| 2021 August | 27 | 36 | 63 |
| 2021 July | 21 | 26 | 47 |
| 2021 June | 17 | 18 | 35 |
| 2021 May | 25 | 42 | 67 |
| 2021 April | 79 | 47 | 126 |
| 2021 March | 52 | 21 | 73 |
| 2021 February | 50 | 19 | 69 |
| 2021 January | 41 | 25 | 66 |
| 2020 December | 30 | 6 | 36 |
| 2020 November | 32 | 10 | 42 |
| 2020 October | 20 | 17 | 37 |
| 2020 September | 64 | 7 | 71 |
| 2020 August | 14 | 8 | 22 |
| 2020 July | 55 | 11 | 66 |
| 2020 June | 38 | 22 | 60 |
| 2020 May | 37 | 6 | 43 |
| 2020 April | 42 | 6 | 48 |
| 2020 March | 55 | 11 | 66 |
| 2020 February | 55 | 21 | 76 |
| 2020 January | 48 | 5 | 53 |
| 2019 December | 35 | 7 | 42 |
| 2019 November | 22 | 4 | 26 |
| 2019 October | 41 | 6 | 47 |
| 2019 September | 26 | 8 | 34 |
| 2019 August | 28 | 3 | 31 |
| 2019 July | 45 | 9 | 54 |
| 2019 June | 34 | 12 | 46 |
| 2019 May | 49 | 7 | 56 |
| 2019 April | 24 | 9 | 33 |
| 2019 March | 120 | 7 | 127 |
| 2019 February | 77 | 8 | 85 |
| 2019 January | 42 | 4 | 46 |
| 2018 December | 51 | 12 | 63 |
| 2018 November | 116 | 4 | 120 |
| 2018 October | 137 | 15 | 152 |
| 2018 September | 57 | 11 | 68 |
| 2018 August | 38 | 12 | 50 |
| 2018 July | 43 | 8 | 51 |
| 2018 June | 68 | 13 | 81 |
| 2018 May | 112 | 18 | 130 |
| 2018 April | 122 | 8 | 130 |
| 2018 March | 160 | 5 | 165 |
| 2018 February | 88 | 7 | 95 |
| 2018 January | 170 | 15 | 185 |
| 2017 December | 189 | 12 | 201 |
| 2017 November | 68 | 19 | 87 |
| 2017 October | 32 | 13 | 45 |
| 2017 September | 34 | 27 | 61 |
| 2017 August | 42 | 19 | 61 |
| 2017 July | 31 | 10 | 41 |
| 2017 June | 34 | 15 | 49 |
| 2017 May | 38 | 11 | 49 |
| 2017 April | 21 | 4 | 25 |
| 2017 March | 36 | 23 | 59 |
| 2017 February | 37 | 12 | 49 |
| 2017 January | 37 | 10 | 47 |
| 2016 December | 59 | 8 | 67 |
| 2016 November | 52 | 10 | 62 |
| 2016 October | 82 | 26 | 108 |
| 2016 September | 89 | 17 | 106 |
| 2016 August | 0 | 2 | 2 |
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